WO2021238633A1 - Expansion balloon device, and method for manufacturing expansion balloon device - Google Patents

Abstract

Provided are an expansion balloon device (100) and a method for manufacturing the expansion balloon device (100). The expansion balloon device (100) comprises a shaft (20), two expandable cage bodies (110, 120) and a flexible wall (30), wherein the two expandable cage bodies (110, 120) are axially arranged on the shaft (20); each of the expandable cage bodies (110, 120) has a contracted state and an expanded state; the flexible wall (30) is connected to the two expandable cage bodies (110, 120); the flexible wall (30) at least partially surrounds a recess between the two expandable cage bodies (110, 120); and the flexible wall (30) can expand with expansion of the expandable cage bodies (110, 120). During expansion of the two expandable cage bodies (110, 120), the recess is always formed between the two expandable cage bodies (110, 120), which facilitates localization of a site of stenosis during dilation of a stenotic valve. The two expandable cage bodies (110, 120) jointly provide an expansion force, so as to enhance the expansion force, which facilitates the expansion. In addition, the flexible wall (30) enhances the attachment of the expansion balloon device (100) to the site of stenosis, thereby reducing the probability of valve injury caused by mechanical expansion of the expansion balloon device (100).

Description

Expanding balloon device and manufacturing method of expanding balloon device

Cross-references to related applications

This disclosure claims the priority of a Chinese patent application filed with the Chinese Patent Office on May 29, 2020, the application number is CN202010479562.4, and the invention title is "Expansion Balloon Device and Method for Making Expansion Balloon Device", and its entire contents Incorporated in this disclosure by reference.

Technical field

The present disclosure relates to the technical field of medical devices, and in particular to an expansion balloon device and a manufacturing method of the expansion balloon device.

Background technique

Inflatable structures, such as balloons, are widely used in medical procedures. The balloon is typically placed within the end of the catheter before the balloon reaches the area of interest. When the balloon reaches the area of interest, the balloon is released from the catheter, and a filling medium is infused into the balloon to inflate the balloon.

The balloon can be configured for heart valve treatment procedures, including during aortic balloon valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI). The balloon can be configured to pre-dilate the narrowed valve site to facilitate the placement of the prosthetic valve, or it can be configured to expand the initially collapsed prosthetic valve when the prosthetic valve is placed and deployed. Existing balloons include balloon-type balloons and non-balloon-type hollow balloons. CN101959478B discloses a hollow balloon applicable to TAVI. The hollow balloon is composed of a single expandable cage with limited expansion force; The balloon is mainly configured as a prosthetic valve that is initially collapsed when the prosthetic valve is placed and deployed, and the middle section of the balloon is convex during expansion. If the balloon is used for pre-expansion of stenosis, the positioning and adhesion are not good. good.

Summary of the invention

According to various embodiments of the present disclosure, an objective is to provide an expansion balloon device and a method for manufacturing the expansion balloon device.

The present disclosure provides an expansion balloon device, including:

axis;

Two expandable cages, the two expandable cages are arranged on the shaft in the axial direction, and each expandable cage has a contracted state and an expanded state;

The flexible wall is connected with the two expandable cages, the flexible wall at least partially surrounds the recess between the two expandable cages, and the flexible wall can expand with the expansion of the expandable cages.

The present disclosure also provides a manufacturing method of the expandable balloon device, the manufacturing method includes:

The proximal end of the first expandable cage, the proximal end of the second expandable cage, the distal end of the first expandable cage, and the distal end of the second expandable cage are moved from the proximal end to the distal end The interval is set on the shaft;

Connect one end of the main body of the first expandable cage to the distal end of the first expandable cage, and connect one end of the main body of the second expandable cage to the proximal end of the second expandable cage, and then Cross the main body of the second expandable cage with the main body of the first expandable cage;

Connect the other end of the main body of the second expandable cage to the distal end of the second expandable cage, and connect the other end of the main body of the first expandable cage to the proximal end of the first expandable cage Connect, complete the axial cross assembly of two expandable cages;

The two ends of the flexible wall are respectively connected to the main body of the first expandable cage and the main body of the second expandable cage.

The details, additional aspects and advantages of one or more embodiments of the present disclosure will be partly given in the following description, and part of them will become obvious from the following description, or be understood through the practice of the present disclosure.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present disclosure more clearly, the following will briefly introduce the drawings needed in the embodiments. It should be understood that the following drawings only show certain embodiments of the present disclosure, and therefore do not It should be regarded as a limitation of the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative work.

Fig. 1 is an exploded view of an expanding balloon device provided by an embodiment of the disclosure;

FIG. 2 is a front view of the expanding balloon device in an expanded state according to an embodiment of the disclosure; FIG.

Fig. 3 is a front view of the expansion balloon device in an expanded state provided by an embodiment of the present disclosure with two expandable cages with flexible walls hidden and arranged axially without crossing;

Fig. 4 is a front view of the expandable balloon device in a contracted state provided by an embodiment of the present disclosure with two expandable cages with flexible walls hidden and arranged axially without crossing;

FIG. 5 is a front view of the expansion balloon device in an expanded state provided by an embodiment of the disclosure with two expandable cages with flexible walls concealed in an axially intersecting arrangement; FIG.

Fig. 6 is a front view of the expandable balloon device with two expandable cages arranged axially and crosswise in a contracted state and with a hidden flexible wall according to an embodiment of the present disclosure;

FIG. 7 is a schematic structural diagram of an expandable cage of an expandable balloon device provided by an embodiment of the disclosure;

Fig. 8 is a front view of an expansion balloon device provided with an axial rigid support provided by an embodiment of the disclosure;

Fig. 9 is a front view of an expanding balloon device provided with a spiral rigid support provided by an embodiment of the disclosure;

FIG. 10 is a perspective view of the expanded balloon device with the membrane in the folded state provided by the embodiment of the disclosure (the blood flow channel is opened); FIG.

FIG. 11 is a perspective view of the expandable balloon device with the membrane in the expanded state (the blood flow channel is closed state) according to an embodiment of the disclosure; FIG.

Figure 12 is an end view of the expandable balloon device (the blood flow channel is opened, showing the assembly relationship between the membrane and the second expandable cage);

Figure 13 is another end view of the expandable balloon device (the blood flow channel is closed, showing the assembly relationship between the membrane and the second expandable cage);

14 is a schematic diagram of a connection between the drive line of the expandable balloon device and two expandable cages according to an embodiment of the disclosure;

15 is a schematic diagram of yet another connection between the drive line of the expandable balloon device and two expandable cages according to an embodiment of the disclosure;

16 is a schematic diagram of the structure of the multi-lumen tube and the outer tube of the expandable balloon device provided by the embodiments of the disclosure;

FIG. 17 is a cross-sectional view of the multi-lumen tube of the expandable balloon device provided by an embodiment of the disclosure.

Icon: 100-expandable balloon device; 110-expandable cage; 111-proximal; 112-distal; 113-body; 120-expandable cage; 121-proximal; 122-distal 123-Main body; 20-Axis; 21-Guide limit part; 30-Flexible wall; 31-Rigid support; 311-Axial rigid support; 312-Spiral rigid support; 40-Membrane; 50- Drive line; 51-main body; 52-first branch; 53-second branch; 540-first mount; 541-second mount; 542-third mount; 543-fourth mount; 60-more Lumen; 61-first lumen; 62-second lumen; 70-overtube.

Detailed ways

In order to make the objectives, technical solutions and advantages of the embodiments of the present disclosure clearer, the technical solutions in the embodiments of the present disclosure will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments These are a part of the embodiments of the present disclosure, but not all of the embodiments. The components of the embodiments of the present disclosure generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

Therefore, the following detailed description of the embodiments of the present disclosure provided in the accompanying drawings is not intended to limit the scope of the claimed present disclosure, but merely represents selected embodiments of the present disclosure. Based on the embodiments in the present disclosure, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of the present disclosure.

It should be noted that similar reference numerals and letters indicate similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

In the description of the present disclosure, it should be noted that the orientation or positional relationship indicated by the terms "inner" and/or "outer" is based on the orientation or positional relationship shown in the accompanying drawings, or is a customary swing when the application product is used. The orientation or positional relationship is only for the convenience of describing the present disclosure and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be construed as essential to the present disclosure. limit. In addition, the terms "first", "second", etc. are only used for distinguishing description, and cannot be understood as indicating or implying relative importance.

In the description of the present disclosure, it should also be noted that, unless otherwise clearly specified and limited, the terms "set" and/or "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. , Or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication between two components. For those of ordinary skill in the art, the specific meanings of the above-mentioned terms in the present disclosure can be understood in specific situations.

Hereinafter, an expansion balloon device 100 according to an embodiment of the first aspect of the present disclosure will be described with reference to the accompanying drawings.

As shown in FIGS. 1 and 2, the expansion balloon device 100 according to the embodiment of the present disclosure includes: a shaft 20, two expandable cages (hollow balloons) 110 and 120 and a flexible wall 30.

The shaft 20 is configured to mount two expandable cages 110,120. The two expandable cages 110 and 120 are arranged on the shaft 20 along the axial direction, and the two expandable cages 110 and 120 are arranged coaxially. Both the expandable cages 110 and 120 have a contracted state and an expanded state, and the expandable cages 110 and 120 can expand radially outward with the shaft 20 as the center. During the expansion of the two expandable cages 110 and 120, a recess is always formed between the two expandable cages 110 and 120. The flexible wall 30 is connected to the two expandable cages 110 and 120, and the flexible wall 30 at least partially surrounds the recess between the two expandable cages 110, 120. The flexible wall 30 can expand with the expansion of the expandable cages 110, 120. When the flexible wall 30 expands with the expandable cages 110, 120, the flexible wall 30 adheres to the stenosis part of the valve and gradually expands the original narrow valve. The positioning of the entire device is realized, and at the same time, it is convenient for the effective transmission of the expansion force.

According to the expandable balloon device 100 of the embodiment of the present disclosure, the two expandable cages 110, 120 and the flexible wall 30 form an organic whole. During the expansion of the two expandable cages 110, 120, the two expandable cages A recess is always formed between the bodies 110 and 120, which facilitates the positioning of the valve during expansion. The two expandable cages 110 and 120 jointly provide the expansion force, so that the expansion force is increased, which is significantly greater than the expansion force of one expandable cage, thereby improving the efficiency of stenosis expansion. In addition, the flexible wall 30 directly contacts the narrow part to be expanded. Compared with the metal balloon, when the material directly contacts the narrow part, the probability of tissue trauma caused by the mechanical expansion of the expanding balloon device 100 is reduced; the flexible wall 30 directly contacts the narrow part to be expanded The contact area of the stenosis is increased compared with that when the metal balloon directly contacts the valve, the adhesion is enhanced, and the expansion force of the expandable cage 110, 120 can be effectively transmitted to the stenosis, which is beneficial to expansion.

Hereinafter, the structural features and connection modes of the components of the expandable balloon device 100 according to the embodiments of the present disclosure will be described with reference to the accompanying drawings.

As shown in Figs. 3-6, two expandable cages 110, 120 are arranged on the shaft 20 along the axial direction, and Figs. 3 and 4 are schematic diagrams of the two expandable cages 110, 120 not intersecting in the axial direction. , Figures 5 and 6 are schematic diagrams of two expandable cages 110 and 120 arranged crosswise in the axial direction.

According to some embodiments of the present disclosure, the materials of the expandable cages 110 and 120 may be nickel titanium alloy (NiTi), stainless steel, etc., which have a certain supporting strength. The material of the flexible wall 30 may be a non-elastic material, such as woven cloth, expanded polytetrafluoroethylene, or a certain elastic material, such as rubber or silicone. The material of the shaft 20 may be stainless steel, which has a certain supporting strength. In other embodiments of the present disclosure, the materials of the expandable cage bodies 110 and 120 and the shaft 20 may also be other metal materials, alloy materials, or non-metallic hard materials.

According to some embodiments of the present disclosure, as shown in FIG. 7, the expandable cage 110 is located at the proximal end, and the expandable cage 120 is located at the distal end. In the present disclosure, the end close to the operator is defined as the proximal end, and the end far away from the operator is defined as the distal end. Specifically, the left end in FIG. 7 is the proximal end, and the right end is the distal end.

The expandable cage 110 includes a proximal portion 111, a distal portion 112, and a hollow main body portion 113. The proximal portion 111 and the distal portion 112 are disposed on the shaft 20 and can move relative to each other (the relative movement here includes the proximal end). The part 111 and the distal part 112 move relative to the shaft 20 at the same time, or one of the proximal part 111 and the distal part 112 moves relative to the shaft 20); the main body part 113 connects the proximal part 111 and the distal part 112 and The external mounting surface is defined, and the flexible wall 30 is connected to the external mounting surface (as shown in FIG. 2). The main body 113 is arranged around the shaft 20. The main body 113 has a certain degree of toughness. When the proximal end 111 and the distal end 112 are close to each other, the main body 113 can be arched. When the expandable cage 110 is in a contracted state, the proximal end 111 and the distal end 112 are separated by a first distance, and when the expandable cage 110 is in an expanded state, the proximal end 111 and the distal end 112 are separated by a second distance, The second distance is smaller than the first distance, that is, in the expanded state, the main body 113 is arched.

The proximal portion 111 and the distal portion 112 are connected by the main body portion 113. When the proximal portion 111 and the distal portion 112 are close to each other, the main body portion 113 can be arched to realize the expansion of the expandable cage 110, and the main body portion 113 functions as The role of support and defines the external mounting surface to facilitate the connection of the flexible wall 30.

The expandable cage 120 includes a proximal portion 121, a distal portion 122, and a hollow main body portion 123. The proximal portion 121 and the distal portion 122 are disposed on the shaft 20 and can move relative to each other (the relative movement here includes the proximal end). The part 121 and the distal part 122 move relative to the shaft 20 at the same time, or one of the proximal part 121 and the distal part 122 moves relative to the shaft 20); the main body part 123 connects the proximal part 121 and the distal part 122 and The external mounting surface is defined, and the flexible wall 30 is connected to the external mounting surface (as shown in FIG. 2). The main body 123 is arranged around the shaft 20, and the main body 123 has a certain degree of toughness. When the proximal end 121 and the distal end 122 are close to each other, the main body 123 can be arched. When the expandable cage 120 is in a contracted state, the proximal end 121 and the distal end 122 are separated by a first distance, and when the expandable cage 120 is in an expanded state, the proximal end 121 and the distal end 122 are separated by a second distance, The second distance is smaller than the first distance, that is, in the expanded state, the main body 123 is arched.

The proximal portion 121 and the distal portion 122 are connected by the main body portion 123. When the proximal portion 121 and the distal portion 122 are close to each other, the main body portion 123 can be arched to realize the expansion of the expandable cage 120, and the main body portion 123 functions as The role of support and defines the external mounting surface to facilitate the connection of the flexible wall 30.

In some embodiments, each of the main body portions 113 and 123 includes a plurality of branches. The two ends of each branch of the main body 113 are respectively connected to the proximal part 111 and the distal part 112, and a plurality of branches are distributed around the shaft 20; the two ends of each branch of the main body 123 are respectively connected to the proximal part 121 and At the distal end 122, a plurality of branches are distributed around the shaft 20. The main body parts 113 and 123 are composed of a plurality of branches, and the overall structure is simple, which is convenient for processing and manufacturing. In other embodiments of the present disclosure, the main body portions 113 and 123 may also have a net-like structure or other irregular hollow structures, and the main body portions 113 and 123 of appropriate shapes are selected according to actual conditions. In the preferred embodiment of the present disclosure, the main body parts 113 and 123 are composed of a plurality of branches.

As an optional method of the present disclosure, the proximal end 111 and the distal end 112 of the expandable cage body 110 are both sleeved on the shaft 20, and the proximal end 121 and the distal end 122 of the expandable cage body 120 are both sleeved on the shaft 20.轴20 on. The connection between the main body 113, 123 and the end (collectively referred to as the proximal end 111, 121 and the distal end 112, 122, the same below) can be a detachable connection, for example, a card slot is provided on the end, and the main body 113 and 123 are inserted into the slot and engaged with the end to facilitate the assembly and disassembly of the main body 113 and 123 and the end. The connection between the main body portions 113 and 123 and the end portions may also be in a non-detachable connection manner, for example, welding or bonding.

According to some embodiments of the present disclosure, the two expandable cage bodies 110 and 120 are arranged according to whether the axial direction is crossed or not, which may include two axial arrangements, refer to FIGS. 3 to 6. It should be noted that, for the purpose of clarity, FIGS. 3 to 6 are schematic diagrams of the expandable balloon device 100 with the flexible wall 30 omitted.

Axial arrangement mode one, as shown in Figs. 3 and 4, the expandable cage body 110 and the expandable cage body 120 are arranged without crossing in the axial direction. The non-intersecting arrangement of the two expandable cages 110 and 120 facilitates the installation of the two expandable cages 110 and 120 on the shaft 20.

Axial arrangement mode two, as shown in Figures 5 and 6, the expandable cage body 110 and the expandable cage body 120 are arranged to cross in the axial direction, that is, the distal end 112 of the expandable cage body 110 is located on the expandable cage body 120 Between the proximal end 121 and the distal end 122 of the expandable cage 120, the proximal end 121 of the expandable cage 120 is located between the proximal end 111 and the distal end 112 of the expandable cage 110. The two expandable cages 110, 120 are axially crossed, and the axial arrangement is compact. The concave positions between the two expandable cages 110, 120 are concentrated during expansion, which is convenient for positioning in use; and the axial arrangement mode In comparison, the middle part of the expansion device composed of two expandable cages 110 and 120 has a larger radial expansion size during expansion, which is more conducive to the expansion of the narrow part. In the preferred embodiment in the present disclosure, the expandable cage body 110 and the expandable cage body 120 are arranged to cross each other in the axial direction.

When the two expandable cages 110 and 120 are arranged in an axially crossed manner, the proximal end 111, the proximal end 121, the distal end 112 and the distal end 122 are first arranged on the shaft at intervals from the proximal end to the distal end. Then connect one end of the main body 113 of the expandable cage 110 to the distal end 112 of the expandable cage 110, and then connect one end of the main body 123 of the expandable cage 120 to the proximal end 121 of the expandable cage 120 , And cross the main body 123 of the expandable cage 120 with the main body 113 of the expandable cage 110, and connect the other end of the main body 123 of the expandable cage 120 with the distal end 122 of the expandable cage 120, Finally, the other end of the main body 113 of the expandable cage 110 is connected with the proximal end 111 of the expandable cage 110 to realize the axial cross assembly of the two expandable cages 110 and 120. After completing the axial cross assembly of the two expandable cages 110 and 120, the two ends of the flexible wall 30 are respectively connected to the main body 113 of the expandable cage 110 and the main body 123 of the expandable cage 120. It should be noted that the assembly method in which the two expandable cages 110 and 120 axially cross is not the only one, and other assembly methods can also be used, as long as the two expandable cages 110 and 120 are arranged in an axially crossed manner.

It should be pointed out that when the expandable cage 110 and the expandable cage 120 do not cross axially, the distal end 112 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 may or may not be in contact.

In some specific embodiments according to the present disclosure, one end of the expandable cage 110 is a fixed end fixed to the shaft 20, and the other end of the expandable cage 110 is a movable end that can move along the shaft 20; One end of the expandable cage 120 is a fixed end fixed to the shaft 20, and the other end of the expandable cage 120 is a movable end that can move along the shaft 20. Equivalently, the expandable cage 110 and the expandable cage 120 are both fixed at one end and movable at the other end. That is, when the expandable cages 110 and 120 are expanded or contracted, only one end moves relative to the shaft 20. In other embodiments of the present disclosure, the two ends of the expandable cage body 110 and the two ends of the expandable cage body 120 may both be configured as moving ends that can move along the shaft 20. When 110 and 120 are expanded or contracted, both ends of the expandable cage body 110 and the two ends of the expandable cage body 120 move relative to the shaft 20.

According to some embodiments of the present disclosure, the flexible wall 30 has a cylindrical structure arranged around the shaft 20 (as shown in FIG. 1), one end of the flexible wall 30 is connected to the outer mounting surface of the expandable cage 110, and the other One end is connected to the outer mounting surface of the expandable cage 120 (as shown in FIG. 2). The cylindrical structure design of the flexible wall 30 allows the flexible wall 30 to fully contact the valve in the circumferential direction, and evenly and effectively transmits the expansion force to the stenosis part of the valve, facilitating the uniform force expansion of the valve. In other embodiments of the present disclosure, the flexible wall 30 may also be a plurality of flexible belts (not shown) distributed around the shaft 20 at intervals. The flexible belts are arranged in parallel with the shaft 20, and the two ends of the flexible belt are respectively connected to the expandable cage body. 110 and the outer mounting surface of the expandable cage 120 are connected.

It should be pointed out that according to the location and number of the mobile terminal, it is divided into two expandable cages 110, 120. During the expansion and contraction process, the center distance of the two expandable cages 110, 120 changes (for example, Figure 14 ) And the center distance remains unchanged (for example, Figure 15).

Under the condition that the center distance between the two expandable cages 110 and 120 is constant, the material of the flexible wall 30 is not limited, and it can be a material with no elasticity or a material with a certain elasticity. When the center distance of the two expandable cages 110 and 120 is changed, the flexible wall 30 may have elasticity to reduce the outer contour of the device when the device is collapsed under the condition of adapting to the center distance change. When the center distance between the two expandable cages 110, 120 is changed, the flexible wall 30 may not have elasticity. For example, the flexible wall 30 may be fabricated. The center distance between the two expandable cages 110, 120 is When changing, the flexible wall 30 unfolds or folds.

In an alternative embodiment, during the expansion process of the expansion balloon device 100, the center distance of the two expandable cages 110, 120 remains unchanged, and the flexible wall 30 is made of a non-elastic material. The flexible wall 30 follows the contraction of the expandable cages 110 and 120 and folds radially without axial folding, and the flexible wall 30 follows the expansion of the expandable cages 110 and 120 to expand radially without stretching in the axial direction.

In another alternative embodiment, during the expansion process of the expansion balloon device 100, the center distance between the two expandable cages 110 and 120 remains unchanged, and the flexible wall 30 adopts an elastic material. When the expandable cage bodies 110 and 120 shrink, the flexible wall 30 can shrink radially without folding in the axial direction. In a preferred embodiment, the flexible wall 30 may not be folded radially when it is radially contracted, that is, when the expandable cage bodies 110 and 120 are expanded, the flexible wall 30 is elastically deformed in the radial direction.

In another alternative embodiment, during the expansion process of the expansion balloon device 100, the center distance between the two expandable cages 110 and 120 becomes longer, and the flexible wall 30 is made of elastic material. When the expandable cage bodies 110 and 120 shrink, the flexible wall 30 can shrink radially without folding in the axial direction. In a preferred embodiment, the flexible wall 30 may not be folded radially when it is radially contracted. For example, the flexible wall 30 is elastically deformed in both the axial direction and the radial direction. At this time, the outer contour of the expansion balloon device 100 in the case of collapse is further reduced.

In another alternative embodiment, during the expansion process of the expansion balloon device 100, the center distance between the two expandable cages 110 and 120 becomes longer, and the flexible wall 30 is made of a non-elastic material. When the expandable cages 110 and 120 contract, the flexible wall 30 folds or collapses in the axial and radial directions; when the expandable cages 110 and 120 expand, the flexible wall 30 expands inelastically in the axial and radial directions.

According to some embodiments of the present disclosure, as shown in FIGS. 8 and 9, a rigid support 31 is provided on the flexible wall 30, which can enhance the rigidity of the flexible wall 30 and facilitate the expansion of the narrow part. In the direction of the shaft 20, the two ends of the rigid support 31 are connected to the two ends of the flexible wall 30.

In some specific embodiments of the present disclosure, the rigid support 31 is provided on the inner surface of the flexible wall 30 or embedded in the flexible wall 30. When the expansion balloon device 100 is expanded, the rigid support 31 may be displaced relative to the stenosis lesion. The rigid support 31 is arranged on the inner surface of the flexible wall 30 or embedded in the flexible wall 30 to prevent the rigid support 31 Abrasive tissue. When the rigid support 31 is embedded in the flexible wall 30, it can be understood that the flexible wall 30 includes two wall films (not shown in the figure), and an accommodation space (not shown in the figure) is formed between the two wall films. , The rigid support 31 is accommodated in the accommodating space; the two ends of the two wall films are fixedly connected to form a closed accommodating space, so as to prevent the rigid support 31 from detaching.

According to some embodiments of the present disclosure, as shown in FIG. 8, the rigid support 31 may be an axial rigid support 311. When the rigid support 31 is an axial rigid support 311, there are multiple axial rigid supports 311, and the multiple axial rigid supports 311 are distributed on the flexible wall 30 along the circumferential direction of the shaft 20, and follow the flexible wall 30. When the expandable cage bodies 110 and 120 are contracted, the plurality of axial rigid supports 311 are gathered toward the shaft 20. The axially rigid support 311 is suitable for the case where the center distance of the two expandable cages 110 and 120 is constant during expansion, and is also suitable for the case where the center distance of the two expandable cages 110 and 120 changes during the expansion. The axial rigid support 311 may be either a stretchable shaft-shaped member or a non-stretchable shaft-shaped member.

In an alternative embodiment, during the expansion process of the expandable balloon device 100, the center distance between the two expandable cages 110 and 120 becomes longer, and the axial rigid support 311 adopts a stretchable shaft-shaped component. The two ends of the axial rigid support 311 are fixedly connected to the flexible wall 30. When the expandable balloon device 100 is expanding or contracting, the flexible wall 30 can drive the axial rigid support 311 to achieve axial stretching or contraction. The rigid support 31 is a stretchable structure that can be extended with the expansion of the two expandable cages 110, 120, and contracted with the contraction of the two expandable cages 110, 120, and provides further expansion for the narrow part when expanded Supporting force, saving space and reducing the volume of the device when shrinking.

In yet another alternative embodiment, during the expansion process of the expandable balloon device 100, the center distance between the two expandable cages 110 and 120 becomes longer, and the axial rigid support 311 adopts a non-stretchable shaft-like component. .

For example, the flexible wall 30 includes a three-section structure sequentially distributed along the axial direction. The first section and the third section at both ends are elastic structures. The first section and the third section are connected to the expandable cage body 110 and the expandable cage respectively. The body 120 is connected, and the second section in the middle has a structure that does not have elasticity. The axial rigid support 311 adopts a non-stretchable shaft-shaped member. The axial rigid support 311 is connected to the second section, and the axial rigid support 311 is connected to the second section. The ends extend to the first and third sections.

For another example, the flexible wall 30 is made of elastic material as a whole, and the axial rigid support 311 is a non-stretchable shaft-shaped member, and the axial rigid support 311 is connected to the flexible wall 30 through at least two connection points on the flexible wall 30, wherein , The connection points are distributed at intervals along the axial direction, and the axial rigid support 311 is slidingly fitted with at least one connection point. In some embodiments, a fixed connection point and at least one movable connection point are provided on the flexible wall 30. The fixed connection point is located at one end of the flexible wall 30, and one end of the axial rigid support 311 is fixedly connected to the fixed connection point. The rigid support 311 is slidably fitted with at least one movable connection point of the flexible wall 30; in another embodiment, a fixed connection point is provided in the middle of the flexible wall 30, and the axial rigid support 311 is fixedly connected to the fixed connection point. The wall 30 is also provided with at least two movable connection points, the at least two movable connection points are located on both sides of the fixed connection point, and the axial rigid support 311 is slidingly fitted with the at least two movable connection points.

According to other embodiments of the present disclosure, as shown in FIG. 9, the rigid support 31 may be a spiral rigid support 312. When the rigid support 31 is a spiral rigid support 312, the spiral rigid support 312 is spirally distributed on the flexible wall 30. The spiral rigid support 312 is suitable for the case where the center distance of the two expandable cages 110 and 120 is constant during expansion, and is also suitable for the case where the center distance of the two expandable cages 110 and 120 changes during the expansion. The two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30. The spiral rigid support 312 can be a stretchable structure (similar to a spring shape, which can achieve axial and radial deformation), or Non-stretchable structure.

In an alternative embodiment, when the expansion balloon device 100 is expanded, the center distance between the two expandable cages 110 and 120 becomes longer, and the spiral rigid support 312 adopts a stretchable spiral component. The two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30. The spiral rigid support 312 is made of a material with a certain degree of toughness. The spiral rigid support 312 produces axial and radial expansion at the same time as the flexible wall 30 expands. (The axial length and diameter become larger at the same time), the helical rigid support 312 follows the contraction of the flexible wall 30 and simultaneously produces axial and radial contraction (the axial length and diameter decrease at the same time).

In another alternative embodiment, the center distance of the two expandable cages 110 and 120 remains unchanged when the expandable balloon device 100 is expanded, and the spiral rigid support 312 adopts a stretchable spiral component. The two ends of the spiral rigid support 312 are fixedly connected to the two ends of the flexible wall 30. The spiral rigid support 312 is made of a material with a certain degree of toughness. The spiral rigid support 312 follows the expansion of the flexible wall 30 to produce radial expansion (the diameter becomes larger And the axial length is unchanged), the spiral rigid support 312 follows the contraction of the flexible wall 30 to produce radial contraction (the diameter becomes smaller and the axial length remains unchanged).

As some optional embodiments of the present disclosure, when the rigid support 31 adopts non-stretchable parts (for example, the axial rigid support 311 and/or the spiral rigid support 312), the rigid support 31 may be provided on the flexible wall 30 The surface of the rigid support 31 is in direct contact with the tissue; the rigid support 31 can also be a sleeve (not shown in the figure, the sleeve can be elastic or inelastic), and the sleeve is sleeved outside the rigid support 31. When the rigid support 31 uses a sleeve, the rigid support 31 can be prevented from directly contacting the tissue. When the expansion balloon device 100 is expanded or contracted, the rigid support 31 will not cause tissue trauma. In the preferred embodiment of the present disclosure, the sleeve is set to be elastic, and the elastic sleeve follows the expansion or contraction of the flexible wall 30 to generate elastic deformation.

According to some embodiments of the present disclosure, the expandable balloon device 100 further includes a membrane 40. The membrane 40 can be arranged on the expandable cage 110, or on the expandable cage 120, or on both of them at the same time. Expandable cage body 110,120.

When the two expandable cages 110 and 120 are not arranged crosswise, the membrane 40 may be arranged at the proximal end or the distal end of the expandable cage 110, or may be arranged at the proximal end or the distal end of the expandable cage 120.

In some embodiments, when two expandable cages 110 and 120 are arranged crosswise, in order to facilitate the installation of the membrane 40, the membrane 40 is arranged at the proximal end of the expandable cage 110 or the distal end of the expandable cage 120.

As shown in Figures 10 and 11, as an optional embodiment, the membrane 40 is arranged in the hemisphere of the expandable cage 120 at the distal end (the hemisphere refers to the expanded state of the expandable cage 120), and the membrane 40 can be The expansion forms the hemispherical thin wall when the expandable cage 120 expands to the maximum. Here, the membrane 40 and the expandable cage 120 may be fixed at intervals, continuously or partially continuously. In some embodiments, the membrane 40 and the expandable cage 120 are spaced and fixed, that is, the membrane 40 and the main body 123 have multiple fixed points in the circumferential direction, and the multiple fixed points are distributed at intervals. Further, the main body portion 123 adopts a structure of multiple branches, the multiple branches are distributed around the shaft 20, the two ends of each branch are respectively connected to the proximal part 121 and the distal part 122, and the membrane 40 is spaced from the multiple branches. Fixed connection (spaced one or more branches). The membrane 40 allows blood to flow from the distal end 122 of the expandable cage 120 to the proximal end 121 and prevents blood from flowing from the proximal end 121 of the expandable cage 120 to the distal end 122.

As another alternative embodiment, the structure and installation position of the membrane 40 can adopt the cover scheme in the patent publication number CN101959478B, that is, the membrane 40 is arranged outside the proximal end of the expandable cage 110, and the membrane 40 is at least partially Surrounding the proximal end of the expandable cage 110, the membrane 40 includes at least one slit and is at least partially separated from the outer surface of the main body portion 113 at the proximal end portion. A plurality of slits may be distributed on the membrane 40 at approximately 120 degrees at the proximal end portion. superior. The proximal part of the membrane 40 is sewn to define a plurality of leaflets. When blood flows through the expandable cage 110 from the distal end to the proximal end, the leaflets can open the blood flow channel, and when the blood tries to flow from the proximal end to the distal end When passing the expandable cage 110, the leaflets can close the blood flow channel.

During the valve expansion medical process, the membrane 40 is contracted or expanded by the blood flow force, and the setting of the membrane 40 limits the unidirectional blood flow to prevent reflux. As shown in FIGS. 11 and 13, the membrane 40 is unfolded to close the blood flow channel; as shown in FIGS. 10 and 12, the membrane 40 is folded to open the blood flow channel. For example, in a procedure of dilating a stenotic aortic valve, when the left ventricle contracts, blood flows from the place where the membrane 40 and the main body 123 of the expandable cage 120 are not fixed, as shown in FIGS. 10 and 12; the left ventricle During diastole, the membrane 40 is in contact with all the main body parts 123 of the expandable cage 120, and the membrane 40 closes the blood flow channel and blocks blood reflux, as shown in FIGS. 11 and 13.

In one or more embodiments, the expansion balloon device 100 further includes a drive wire 50. As shown in Figures 14 and 15, the drive line 50 is connected to the moving end of the expandable cage 110 and the moving end of the expandable cage 120, and the drive line 50 is configured to control the moving end of the expandable cage 110 and the expandable cage. The movable end of the body 120 moves, thereby facilitating the expansion of the expandable cage bodies 110 and 120. The movement of the moving end of the expandable cage 110 and the moving end of the expandable cage 120 is controlled by the drive line 50, which is convenient to realize the control of the expansion of the two expandable cages 110, 120, and the operation is convenient.

It should be pointed out that in other embodiments of the present disclosure, the drive line 50 may be provided with two branches. At this time, the expandable cage bodies 110 and 120 only need to be provided with one moving end, and the two branch drive lines correspond to the expandable cages. Each branch drive line corresponding to the moving end of the body 110 and the moving end of the expandable cage 120 drives one expandable cage, so as to realize the simultaneous expansion or asynchronous expansion of the two expandable cages 110 and 120. The drive line 50 can also be provided with three or four branches. At this time, three or four of the four ends of the two expandable cages 110 and 120 are set as moving ends, and each branch drive line drives one to move. Each branch drive line drives the corresponding mobile end to move, so as to realize the expansion or contraction of the expandable cages 110 and 120.

In order to ensure that the expandable cage body 110 and the expandable cage body 120 can maintain the expanded state, a locking member (not shown in the figure) is provided at the proximal end of the shaft 20 or the user's operating end, and the locking member is configured to be driven by the drive line 50 After the two expandable cages 110, 120 are expanded to the expanded state, the drive line 50 is locked to ensure that the two expandable cages 110, 120 are locked in the expanded state.

According to some embodiments of the present disclosure, as shown in FIGS. 14 and 15, the driving wire 50 includes a main body 51, a first branch 52, and a second branch 53, one end of the first branch 52 is connected to the main body 51, and the first branch 52 The other end is connected to the moving end of the expandable cage body 110, one end of the second branch 53 is connected to the main body 51, and the other end of the second branch 53 is connected to the moving end of the expandable cage body 120. The main body 51 is connected to the first branch 52 and the second branch 53, and by controlling the movement of the main body 51, the movement control of the moving ends of the two expandable cages 110, 120 is realized, and the movement of the two expandable cages 110, 120 is realized. Expansion or contraction.

As shown in FIGS. 14 and 15, the following takes the expansion balloon device 100 in which two expandable cage bodies 110 and 120 are axially crossed as an example to introduce two connection modes of the drive line 50. It should be noted that, for the purpose of clarity, FIGS. 14 and 15 are both schematic diagrams of the expansion balloon device 100 with the flexible wall 30 omitted.

FIG. 14 schematically shows the connection details of the drive line 50 with a longer center distance between the expandable cage 110 and the expandable cage 120 during the expansion and contraction of the expandable balloon device 100. The proximal end 111 of the expandable cage 110 is the fixed end, and the distal end 112 of the expandable cage 110 is the mobile end; the proximal end 121 of the expandable cage 120 is the mobile end, and the distal end of the expandable cage 120 The part 122 is a fixed end; the distal end 122 of the expandable cage 120 is provided with a first wire-passing hole (not shown in the figure), the first wire-passing hole is for the second branch 53 to pass through; the second branch 53 is far away One end of the main body 51 passes through the first wire-passing hole and is connected to the proximal end 121 of the expandable cage 120. The distal end 122 of the expandable cage 120 functions as a fulcrum to facilitate the support of the second branch 53. The driving wire 50 can control the distal end 112 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 to move in opposite directions, so as to realize the expansion or contraction of the two expandable cages 110 and 120. When the driving wire 50 is pulled to move proximally, the distal end 112 of the expandable cage 110 moves proximally, and the proximal end 121 of the expandable cage 120 moves distally, and the expandable balloon device 100 expands. When the drive wire 50 is loosened, the distal end 112 of the expandable cage 110 moves distally, and the proximal end 121 of the expandable cage 120 moves proximally, and the expandable balloon device 100 contracts. The proximal end 111 of the expandable cage 110 and the distal end 122 of the expandable cage 120 are fixed ends, so that when the expandable cages 110 and 120 are expanded, the distal end 112 of the expandable cage 110 and the expandable The proximal end 121 of the cage 120 moves in the opposite direction, so as to ensure that both ends of the flexible wall 30 are pulled and expanded synchronously. In this form, the occupied length of the expansion balloon device 100 composed of two expandable cages 110 and 120 on the shaft 20 does not change.

FIG. 15 schematically shows the connection details of the drive line 50 with a constant center distance between the expandable cage 110 and the expandable cage 120 during the expansion and contraction of the expandable balloon device 100. Compared with Figure 14, the difference is that the proximal end 121 of the expandable cage 120 is a fixed end, the distal end 122 of the expandable cage 120 is a mobile end, and the second branch 53 is directly connected to the expandable cage 120. The distal end 122 is connected. When the driving wire 50 is pulled to move proximally, the distal end 112 of the expandable cage 110 and the distal end 122 of the expandable cage 120 both move proximally, and the expandable balloon device 100 expands. The slack drive wire 50, the distal end 112 of the expandable cage 110 and the distal end 122 of the expandable cage 120 all move to the distal end, and the expandable balloon device 100 contracts. The proximal end 111 of the expandable cage 110 and the proximal end 121 of the expandable cage 120 are both fixed ends. When the expandable cages 110 and 120 are expanded, the distal end 112 of the expandable cage 110 and the expandable The distal end 122 of the cage 120 moves toward the respective proximal end, and the length of the expansion balloon device 100 composed of two expandable cages 110 and 120 on the shaft 20 is reduced.

In some specific embodiments of the present disclosure, in order to ensure that the main body 51 drives the first branch 52 and the second branch 53 to move flexibly, the fixed end of the first expandable cage 110 is provided with a second wire passing hole (not shown in the figure).出), the main body 51 is inserted into the second cable-passing hole. As shown in Figures 14 and 15, the proximal end 111 of the expandable cage 110 is a fixed end, the proximal end 111 of the expandable cage 110 is provided with a first mounting seat 540, and the second cable hole is opened in the first On the mounting seat 540, the main body 51 passes through the second cable hole on the first mounting seat 540 and can move relative to the proximal end 111 of the expandable cage body 110, thereby driving the first branch 52 and the second branch 53 to be relatively于轴20 Moves. In order to facilitate the connection between the drive line 50 and the end, the distal end 112 of the expandable cage body 110 is provided with a second mounting seat 541, and the proximal end 121 of the expandable cage body 120 is provided with a third mounting seat 542. The distal end 122 of the body 120 is provided with a fourth mounting seat 543.

As shown in FIG. 14, the fourth mounting seat 543 is provided with a first cable-passing hole, and the second branch 53 passes through the first cable-passing hole and is connected to the third mounting seat 542; in order to avoid the first branch 52 and the second branch 53 interference, the second mounting seat 541 on the distal end 112 of the expandable cage body 110 is located below the shaft 20, and the third mounting seat 542 on the proximal end 121 of the expandable cage body 120 is located above the shaft 20; at the same time; , Under the shaft 20, the second branch 53 is located under the first branch 52 to avoid interference between the first branch 52 and the second branch 53. The first cable-passing hole can extend in a direction perpendicular to the shaft 20; the first cable-passing hole can also be an arc-shaped hole, which extends around the circumference of the shaft 20, and the two ports of the first cable-passing hole are located in the center of the shaft 20 Both sides of the line. As shown in FIG. 15, the proximal end 121 of the expandable cage 120 is not connected to the second branch 53, so the proximal end 121 may not be provided with a mounting seat. In some specific embodiments of the present disclosure, when the two expandable cages 110 and 120 are axially crossed, the two moving ends (for example, the distal ends 112 and 122) are a movable unit with a fixed distance, which drives any one of them. The mobile terminal makes the two mobile terminals move synchronously.

According to some embodiments of the present disclosure, as shown in FIG. 16, the expansion balloon device 100 further includes a multi-lumen tube 60 and an overtube 70.

The multi-lumen tube 60 is located at the proximal end of the shaft 20 relative to the expandable cage 110 and the expandable cage 120. As shown in FIG. 17, the multi-lumen tube 60 is provided with a first lumen 61 and a second lumen 62. The proximal end of 20 passes through the first cavity 61, and the proximal end of the drive wire 50 passes through the second cavity 62. The driving wire 50 can move relative to the multi-lumen tube 60 to realize the movement control of all the moving ends of the two expandable cages 110 and 120. The first lumen 61 and the second lumen 62 of the multi-lumen tube 60 accommodate the shaft 20 and the drive wire 50 respectively, so that the drive wire 50 can move flexibly relative to the shaft 20 and play a role of guiding and supporting the drive wire 50.

The outer sleeve 70 is slidably sleeved on the multi-lumen tube 60. When the two expandable cages 110 and 120 are in a contracted state, the outer sleeve 70 can move relative to the multi-lumen tube 60 to connect the two expandable cages 110, 120 120 is housed in the outer sleeve 70. When the two expandable cages 110 and 120 are housed in the outer sleeve 70, it is convenient for the entire expansion balloon device 100 to move in a duct (for example, a blood vessel). After the two expandable cages 110, 120 extend out of the outer sleeve 70, the drive line 50 can control the expansion or contraction of the two expandable cages 110, 120.

In one or more embodiments, as shown in FIG. 16, the distal end of the shaft 20 is provided with a guiding and limiting portion 21, and the distal end of the guiding and limiting portion 21 is set in an arrow-like shape to facilitate the shaft 20 to move in the pipe. ; The size of the guide limiting portion 21 is greater than the diameter of the shaft 20, and the distal end 122 of the expandable cage 120 is restricted to prevent the expandable cage 120 from being separated from the shaft 20 at the distal end.

The working principle of the expansion balloon device 100 according to the embodiment of the present disclosure is:

The two expandable cages 110, 120 and the flexible wall 30 are arranged on the shaft 20 in the axial direction (the membrane 40 has been installed on the expandable cage 120), and the flexible wall 30 is located on the two expandable cages 110, 120, the two ends of the flexible wall 30 are respectively connected to the two expandable cages 110, 120; the shaft 20 is inserted into the first lumen 61 of the multi-lumen tube 60, and the far end of the drive line 50 The end is connected with the moving ends of the two expandable cages 110 and 120, the proximal end of the driving wire 50 is inserted into the second lumen 62 of the multi-lumen tube 60; the outer sleeve 70 is sleeved outside the multi-lumen tube 60. When in use, the shaft 20 and the two expandable cages 110, 120 are sent to the desired position, so that the two expandable cages 110, 120 are exposed from the outer sleeve 70, and the two expandable cages 110 are controlled by the drive line 50 , 120 expansion or contraction.

According to the expandable balloon device 100 of the embodiment of the present disclosure, during the expansion process of the two expandable cages 110, 120, a recess is always formed between the two expandable cages 110, 120, which facilitates the positioning of the stenosis during expansion; the two expandable cages 110, 120 The expansion force of 120 is enhanced; the adhesion between the flexible wall 30 and the valve is enhanced, which is more conducive to the expansion of the valve.

It should be noted that, in the case of no conflict, the features in the embodiments of the present disclosure can be combined with each other. Although the specific embodiments discussed above describe a device configured to pre-dilate a stenotic aortic valve, it should be understood that the expansion balloon device 100 disclosed herein can be used for the expansion of other stenosis lesions, and can also be used for prosthetic valves. Expansion during deployment. For example, the expandable balloon device 100 disclosed herein can be configured to replace expandable balloon elements in many types of medical procedures. Therefore, the expandable balloon device 100 described herein can be used in, for example, angioplasty (e.g., opening of an infarcted coronary artery), valvuloplasty (e.g., expansion of a stenotic heart valve), and other procedures that conventionally employ expanding balloon elements.

The foregoing descriptions are only preferred embodiments of the present disclosure, and are not intended to limit the present disclosure. For those skilled in the art, the present disclosure may have various modifications and changes. Any modification, equivalent replacement and/or improvement made within the spirit and principle of the present disclosure shall be included in the protection scope of the present disclosure.

Claims (17)

1. An expandable balloon device, which is characterized in that it comprises:

   axis;

   Two expandable cages, the two expandable cages are arranged on the shaft along the axial direction, and each expandable cage has a contracted state and an expanded state; and

   A flexible wall that is connected to the two expandable cages, the flexible wall at least partially surrounds the recess between the two expandable cages, and the flexible wall can follow the expandable cages The expansion and expansion.
2. The expandable balloon device according to claim 1, wherein the two expandable cages comprise a first expandable cage at the proximal end and a second expandable cage at the distal end, each of which can The expanded cage-shaped body includes a proximal end, a distal end, and a hollow main body. The proximal end and the distal end are disposed on the shaft and movable relative to each other, and the main body is connected to the proximal end. And the distal end portion and define an external mounting surface, and the flexible wall is connected to the external mounting surface;

   When the expandable cage is in the contracted state, the proximal end and the distal end are separated by a first distance, and when the expandable cage is in the expanded state, the proximal end and The distal portions are separated by a second distance, and the second distance is less than the first distance.
3. The expandable balloon device according to claim 2, wherein the main body portion includes a plurality of branches, and two ends of each branch are respectively connected to the proximal end and the distal end, and the multiple The branches are distributed around the axis.
4. The expandable balloon device according to claim 2, wherein the first expandable cage body and the second expandable cage body are arranged to cross in an axial direction;

   Or, the first expandable cage body and the second expandable cage body are not arranged to cross in the axial direction.
5. The expandable balloon device according to claim 2, wherein the flexible wall is a cylindrical structure arranged around the shaft, and one end of the flexible wall is connected to the outer installation of the first expandable cage Surface, the other end of the flexible wall is connected to the outer mounting surface of the second expandable cage;

   Or, the flexible wall includes a plurality of flexible belts, the plurality of flexible belts are distributed around the axis at intervals, each flexible belt is arranged in parallel with the axis, and one end of each flexible belt is connected to the first expandable The outer mounting surface of the cage, and the other end of each flexible band is connected to the outer mounting surface of the second expandable cage.
6. The expandable balloon device according to claim 5, wherein a rigid support is provided on the flexible wall.
7. The expandable balloon device according to claim 6, wherein the rigid support is provided on the inner surface of the flexible wall or embedded in the flexible wall.
8. The expandable balloon device according to claim 6, wherein the rigid support is a stretchable structure.
9. The expandable balloon device according to claim 8, wherein the rigid support is a stretchable shaft-shaped member, and a plurality of the rigid supports are arranged along the circumferential direction of the flexible wall, the The rigid support is arranged parallel to the shaft, and both ends of the rigid support are fixedly connected to the flexible wall;

   Or, the rigid support is a stretchable spiral component, the rigid support is spirally distributed on the flexible wall, and both ends of the rigid support are fixedly connected to the flexible wall.
10. The expandable balloon device of claim 2, wherein the expandable balloon device further comprises:

    A membrane, the membrane is arranged on the second expandable cage and/or the first expandable cage, and the membrane is configured to prevent blood reflux at the expanded site.
11. The expandable balloon device according to claim 10, wherein the membrane is disposed in the hemisphere at the distal end of the second expandable cage and is in contact with the main body of the second expandable cage. Spaced and fixedly connected, the membrane allows blood to flow from the distal end to the proximal end of the second expandable cage, and prevents blood from flowing from the proximal end to the distal end of the second expandable cage.
12. The expandable balloon device of claim 2, wherein

    The distal end of the first expandable cage is configured as the moving end of the first expandable cage;

    The proximal end or the distal end of the second expandable cage is configured as the mobile end of the second expandable cage;

    The expansion balloon device further includes a drive wire configured to drive the moving end of the first expandable cage and the moving end of the second expandable cage to move.
13. The expandable balloon device according to claim 12, wherein the drive wire comprises a main body, a first branch and a second branch, one end of the first branch is connected to the main body, and the first branch is connected to the main body. The other end is connected to the moving end of the first expandable cage, one end of the second branch is connected to the main body, and the other end of the second branch is connected to the moving end of the second expandable cage .
14. The expandable balloon device according to claim 13, wherein the proximal end of the first expandable cage is a fixed end, and the distal end of the first expandable cage is a mobile end. The proximal end of the second expandable cage is a moving end, the distal end of the second expandable cage is a fixed end, and the fixed end of the second expandable cage is provided with a first wire passing hole, so The second branch passes through the first wire hole and is connected to the moving end of the second expandable cage, and the drive line can control the moving end of the first expandable cage and the second The moving end of the expandable cage moves in the opposite direction;

    Or, the proximal end of the first expandable cage is a fixed end, the distal end of the first expandable cage is a moving end, and the proximal end of the second expandable cage is a fixed end, The distal end of the second expandable cage is a moving end, and the drive line can control the moving end of the first expandable cage and the moving end of the second expandable cage to move in the same direction .
15. The expandable balloon device according to claim 14, wherein the fixed end of the first expandable cage is provided with a second wire passing hole, and the main body passes through the second wire passing hole.
16. The expandable balloon device according to any one of claims 1-15, wherein the flexible wall is made of an elastic material.
17. A manufacturing method of an expandable balloon device, characterized in that, the manufacturing method includes:

    The proximal end of the first expandable cage, the proximal end of the second expandable cage, the distal end of the first expandable cage, and the distal end of the second expandable cage are moved from the proximal end to the distal end The interval is set on the shaft;

    Connect one end of the main body of the first expandable cage to the distal end of the first expandable cage, and connect one end of the main body of the second expandable cage to the proximal end of the second expandable cage, and then Cross the main body of the second expandable cage with the main body of the first expandable cage;

    Connect the other end of the main body of the second expandable cage to the distal end of the second expandable cage, and connect the other end of the main body of the first expandable cage to the proximal end of the first expandable cage Connect to complete the axial cross assembly of the two expandable cages; and

    The two ends of the flexible wall are respectively connected to the main body of the first expandable cage and the main body of the second expandable cage.

Images